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Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial

NCT04175470•Vejle Hospital

Summary

A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood. The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only. When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did. Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed epithelial ovarian cancer, primary fallopian or primary peritoneal cancer.
•Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
•Progression on previous treatment. Previous treatment with bevacizumab is allowed.
•Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
•Age ≥ 18 years.
•Performance status 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
•* WBC ≥ 3.0 x 10\^9/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l
•* Platelet count ≥ 100 x 10\^9/l
•* Hemoglobin ≥ 6 mmol/l
+5 more criteria

Exclusion Criteria

•Other malignant disease within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
•Underlying medical disease not adequately treated (diabetes, cardiac disease).
•Uncontrolled hypertension (BP \> 150/100 despite antihypertensive treatment).
•Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab.
•Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment.
•Clinical significant cardiovascular disease, including:
•* Myocardial infarction or unstable angina within 6 months before start of treatment
•* New York Heart Association (NYHA) class ≥ 2
+6 more criteria

Locations (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark

Key Dates

Start Date

October 29, 2019

Primary Completion Date

July 30, 2024

Completion Date

December 31, 2024

Last Updated

January 3, 2025

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer Recurrent

Interventions

Bevacizumab

DRUG

Tocotrienol

DIETARY_SUPPLEMENT

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

NCT06888921

Ovarian CancerOvarian Cancer Recurrent

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UNKNOWNPHASE1/PHASE2

Adoptive T Cell Therapy in Patients With Recurrent Ovarian Cancer

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Ovarian Cancer Recurrent

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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